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1. HISTORICAL

   

   ISPE draft▹

   This document has been replaced. View the most recent version.

   DRAFT***GAMP Good Practice Guide: Enabling Innovation

   Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, .

   Languages:

   Historical Editions: GAMP Good Practice Guide: Enabling Innovation, Draft publication Good Practice Guide: Enabling Innovation

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2. MOST RECENT

   

   ISPE Readiness Report Bundle▹

   Report on ISPE Work to Support Establishment of the European Union Health Emergency Preparedness and Response Authority (HERA) and Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients

   Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2023.

   Languages: English

   Priced From:

   • $150 Secure PDF

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3. HISTORICAL

   

   ISPE Baseline Guide: Volume 4 - Water and Steam Systems▹

   This document has been replaced. View the most recent version.

   Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2001.

   Languages:

   Historical Editions: ISPE Baseline Guide: Volume 4 - Water and Steam Systems, Third Edition, ISPE Baseline Guide: Volume 4 - Water and Steam Systems, Second Edition

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4. HISTORICAL

   

   ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities▹

   This document has been replaced. View the most recent version.

   Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 06/01/2004.

   Languages:

   Historical Editions: ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities, ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities

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5. HISTORICAL

   

   GAMP Good Practice Guide: Calibration Management▹

   This document has been replaced. View the most recent version.

   Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2001.

   Languages:

   Historical Editions: GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Second Edition

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6. HISTORICAL

   

   ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment▹

   This document has been replaced. View the most recent version.

   Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2005.

   Languages:

   Historical Editions: ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment

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7. HISTORICAL

   

   GAMP Good Practice Guide: Validation of Laboratory Computerized Systems▹

   This document has been replaced. View the most recent version.

   Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 04/01/2005.

   Languages:

   Historical Editions: GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)

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8. MOST RECENT

   

   GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures▹

   Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2005.

   Languages: English

   Priced From:

   • $460 Secure PDF

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9. HISTORICAL

   

   ISPE GAMP Good Practice Guide: Global Information Systems Control and Compliance▹

   This document has been replaced. View the most recent version.

   Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2005.

   Languages:

   Historical Editions: ISPE GAMP Good Practice Guide: Global Information Systems Control and Compliance (Second Edition)

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10. HISTORICAL

    

    ISPE Baseline Guide: Volume 5 - Commissioning and Qualification▹

    This document has been replaced. View the most recent version.

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 03/01/2001.

    Languages:

    Historical Editions: ISPE Baseline Guide: Volume 5 - Commissioning and Qualification, 2nd Edition, ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment

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